PART CDrugs (continued)

DIVISION 7Sale of Drugs for the Purposes of Implementing the General Council Decision (continued)

Application

C.07.002 This Division applies to the sale of drugs for the purposes of implementing the General Council Decision.

SOR/2005-141, s. 1.

Application for Authorization

C.07.003 An application by a manufacturer for authorization to sell a drug under this Division shall be submitted to the Minister and shall contain the following information and documents:

(a) a statement that the manufacturer intends to file an application with the Commissioner of Patents under section 21.04 of the Patent Act;

(b) in respect of a new drug, the submission number and date of filing of the new drug submission or abbreviated new drug submission filed under section C.08.002 or C.08.002.1, respectively, and of any supplement filed under section C.08.003 in respect of the drug;

(i) the application number and date of filing of the application that has been filed under section C.01.014.1 in respect of the drug, or

(ii) the drug identification number, if one has been assigned in respect of the drug pursuant to section C.01.014.2;

(d) for a drug in a solid dosage form, the manner in which the drug is marked in accordance with paragraph C.07.008(a) and evidence that such manner does not alter the safety and efficacy of the drug;

(e) for a drug in a dosage form that is not solid, the manner in which the immediate container is marked in accordance with paragraph C.07.008(a); and

(f) a sample of the label for the drug that includes the information required by paragraph C.07.008(c).

SOR/2005-141, s. 1.

Authorization

C.07.004 The Minister shall notify the manufacturer and the Commissioner of Patents for the purposes of paragraph 21.04(3)(b) of the Patent Act that the manufacturer’s drug meets the requirements of the Act and these Regulations if

(a) the manufacturer has submitted to the Minister an application in accordance with section C.07.003 and a copy of the application filed by the manufacturer with the Commissioner of Patents under section 21.04 of the Patent Act;

(b) in respect of a new drug, an examination of the new drug submission or abbreviated new drug submission or supplement to either submission by the Minister demonstrates that the submission or supplement complies with section C.08.002, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1;

(c) in respect of a drug that is not a new drug, a drug identification number has been assigned pursuant to section C.01.014.2; and

(d) the Minister is satisfied that the manufacturer and the drug comply with the Act and these Regulations.

SOR/2005-141, s. 1.

C.07.005 Despite sections C.01.014, C.08.002 and C.08.003, a manufacturer may sell a drug under this Division if

(a) the Minister has notified the Commissioner of Patents for the purposes of paragraph 21.04(3)(b) of the Patent Act that the drug meets the requirements of the Act and these Regulations; and

(b) the manufacturer has received authorization under section 21.04 of the Patent Act.

SOR/2005-141, s. 1.

C.07.006 Sections C.01.005 and C.01.014.1 to C.01.014.4 do not apply to new drugs sold under this Division.

SOR/2005-141, s. 1.

Notice to Commissioner of Patents

C.07.007 The Minister shall notify the manufacturer and the Commissioner of Patents for the purposes of paragraph 21.13(b) of the Patent Act in the event that the Minister is of the opinion that the manufacturer’s drug authorized to be sold under this Division has ceased to meet the requirements of the Act and these Regulations.

SOR/2005-141, s. 1.

Marking and Labelling

(a) the drug itself permanently bears the mark “XCL”, in the case of a drug in a solid dosage form, or the immediate container permanently bears the mark “XCL”, in the case of a drug in a dosage form that is not solid;

(b) the colour of the drug itself is significantly different from the colour of the version of the drug sold in Canada, in the case of a drug in a solid dosage form; and

(c) the label of the drug permanently bears the mark “XCL”, followed by the export tracking number assigned by the Minister under section C.07.009 and the words “FOR EXPORT UNDER THE GENERAL COUNCIL DECISION. NOT FOR SALE IN CANADA.” or “POUR EXPORTATION AUX TERMES DE LA DÉCISION DU CONSEIL GÉNÉRAL. VENTE INTERDITE AU CANADA.”

SOR/2005-141, s. 1.

C.07.009 The Minister shall assign an export tracking number to each drug in respect of which the Minister has notified the Commissioner of Patents under section C.07.004.

SOR/2005-141, s. 1.

Records

C.07.010 The manufacturer shall, with respect to a drug authorized to be sold under this Division,

(a) establish and maintain records, in a manner that enables an audit to be made, respecting the information referred to in subsection C.08.007(1), and retain those records for at least seven years from the day on which they were established; and

(b) provide to the Minister the summaries referred to in section C.08.008.

Notice to Minister

C.07.011 The manufacturer shall notify the Minister in writing not less than 15 days before commencing the manufacture of the first lot of a drug authorized to be sold under this Division and not less than 15 days before the exportation of each subsequent lot of the drug.

SOR/2005-141, s. 1.

DIVISION 8

New Drugs

C.08.001 For the purposes of the Act and this Division, new drug means a drug, other than a veterinary health product,

(a) that contains or consists of a substance, whether as an active or inactive ingredient, carrier, coating, excipient, menstruum or other component, that has not been sold as a drug in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that substance for use as a drug;

(b) that is a combination of two or more drugs, with or without other ingredients, and that has not been sold in that combination or in the proportion in which those drugs are combined in that drug, for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that combination and proportion for use as a drug; or

(c) with respect to which the manufacturer prescribes, recommends, proposes or claims a use as a drug, or a condition of use as a drug, including dosage, route of administration or duration of action, and that has not been sold for that use or condition of use in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that use or condition of use of that drug.

(a) a drug in respect of which a notice of compliance is issued under section C.08.004 or C.08.004.01 and which is marketed in Canada by the innovator of the drug,

(b) a drug, acceptable to the Minister, that can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, where a drug in respect of which a notice of compliance has been issued under section C.08.004 or C.08.004.01 cannot be used for that purpose because it is no longer marketed in Canada, or

(c) a drug, acceptable to the Minister, that can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, in comparison to a drug referred to in paragraph (a); (produit de référence canadien)

pharmaceutical equivalent

pharmaceutical equivalent means a new drug that, in comparison with another drug, contains identical amounts of the identical medicinal ingredients, in comparable dosage forms, but that does not necessarily contain the same non-medicinal ingredients; (équivalent pharmaceutique)

specifications

specifications means a detailed description of a new drug and of its ingredients and includes

(a) a statement of all properties and qualities of the ingredients that are relevant to the manufacture and use of the new drug, including the identity, potency and purity of the ingredients,

(b) a detailed description of the methods used for testing and examining the ingredients, and

(c) a statement of the tolerances associated with the properties and qualities of the ingredients. (spécifications)